WAYNE, N.J. Teva Pharmaceutical Industries admitted before a federal court Thursday to making false statements about the generic oral contraceptive Gianvi (drospirenone and ethinyl estradiol), a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.
Bayer had sued Teva in the U.S. District Court for the Northern District of Illinois for false advertising and patent infringement, accusing the world’s largest generic drug maker of falsely claiming in Gianvi’s prescribing information that the ethinyl estradiol uses the chemical beta-cyclodextrin as a “clathrate” to stablize it and prolong its shelf life, a patented Bayer technology. In its lawsuit, Bayer said an analysis of Gianvi found it did not use beta-cyclodextrin as a clathrate.
Teva said it would rectify the situation by sending weekly e-mails and faxes to pharmacists throughout the United States for three months that contain corrected prescribing information and had already provided the corrected information to the Food and Drug Administration. It also agreed not to ship any more Gianvi products containing any material claiming that the drug uses beta-cyclodextrin as a clathrate.
Teva received FDA approval for its version of the drug on June 1. Yaz had $782 million in sales in 2009, according to IMS Health.